Medline Convenience Kits Recalled for Sterilization Calibration Issues
Medline is recalling multiple convenience kits used in catheterization labs and surgical procedures due to calibration issues with sterilization equipment that may affect sterility assurance. The affected kits were distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving medical devices used in invasive procedures where compromised sterility assurance could result in patient infection or serious injury. Class II recalls with potential for serious patient harm are classified as Severe per the rubric.
Plain-English summary
Medline Industries, LP is recalling 6,961 units of multiple Medline Convenience Kits, including Angio Procedure Packs, Endo Kits, Angiography Packs, and related surgical procedure kits. These kits are used in medical procedures including angiography, endoscopy, biopsy, and general surgical applications.
The recall was initiated due to calibration issues identified in the equipment used to sterilize and package these devices. Although all products were exposed to validated sterilization and packaging cycles, the calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products.
These kits have been distributed nationwide throughout the United States. Healthcare facilities and providers who have received these products should verify lot numbers and contact Medline for specific instructions regarding the affected units. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; 2) ENDO KIT W/SYRINGE, Model Number:DYKE1743; 3) BGMC ANGIOGRAPHY PACK-LF, Model Number:DYNJ0800934D; 4) GENERAL ENDO PACK-LF, Model Number:DYNJ0842873J; 5) ANGIO PROCEDURE PACK, Model Number:DY
- Manufacturer
- Medline Industries, LP
- Hazard
- sterilization-failure
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) 00-401824AA
- UDI-DI: 10193489455885(each)
- 40193489455886(case)
- Lot Number: 23ABN008
- 2) 00-401824AA
- Lot Number: 23CBM469
- 3) 00-401824AA
- Lot Number: 23EBH500
- 4) 00-401824AA
- Lot Number: 23GBE369
- 5) 00-401824AA
- Lot Number: 23IBE051
- 6) 00-401824AA
- Lot Number: 23IBU695
- 7) 00-401824AA
- Lot Number: 23KBD600
- 8) 00-401824AA
- Lot Number: 23LBC152
- 9) 00-401824AA
- Lot Number: 24ABR800
Distribution
Distributed nationwide across the United States.